Post Market Quality Lab Supervisor - Ludwigshafen am Rhein, Deutschland - ABBVIE
Beschreibung
A career where all your skills can come into play? We Offer That.
A task that meets your passionate approach? We Offer That.
Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to work closely with us to address the health challenges of tomorrow.
In our Post Market Quality Organization at the Ludwigshafen site, you will join a team of talented people and experienced experts in the manufacturing and global distribution of our approved and pipeline products - working with some of the most advanced technologies in the world.
Post Market Quality Lab Supervisor (all genders).
As Post Market Quality Assurance Laboratory Supervisor you are responsible for leading the complaint laboratory analyst team.
Make an impact - being:
- responsible for management of Post Market Quality Assurance Complaint Sample Return lab, including personnel and product complaint documentation, and investigations.
- responsible for the operations and function of the laboratory group which includes lab safety management, training, GxP, metrics and timeliness, continuous improvement and project oversight.
- the designer of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. You may be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
- responsible for developping staffing requirements, supervising a combination of exempt and nonexempt employees and ensure training and development plans are current and executed.
- accountable for making independent compliant decisions based on knowledge of regulatory requirements.
- in the driver seat for initiating, managing and executing projects to continuously improve the overall effectiveness of the department.
- responsible for maintaining Data Integrity standards and assure GMP documentation standards.
This is how you can make a difference:
- Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
- at least 3 years Supervisory experience, quality assurance experience preferred (solid understanding of GxP requirements)
- Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations.
- Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, combination and pharmaceutical products.
- Ability to utilize scientific education and leadership experience to support laboratory testing within a GMP environment to oversee personnel and product complaint return sample testing activities.
- Experience with working in both team setting, cross functionally and independently.
- Project management experience and strong leadership ability, ability to communicate quality requirements effectively and timely and manage small to medium sized quality related projects.
- Strong oral and written communication skills needed.
What we offer:
- a diverse area of work where you can make a real difference
- an open company culture
- attractive remuneration
- intensive onboarding by a mentor
- flexible work models for a healthy work-life balance
- corporate health management with comprehensive health and exercise programs
- corporate social benefits
- diverse career options in an international organization
- high-level, attractive career development opportunities
- a strong international network
At AbbVie, your individual contributions count - help us achieve more together. Be a part of it and grow with us - go above and beyond
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